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Healthcare & FDA

FDA Expands Casgevy to Kids as Young as 2 — Vertex and CRISPR Therapeutics Get a Bigger Market

The label expansion for the first CRISPR gene therapy now covers pediatric sickle cell patients, widening the addressable pool for a $2M-plus treatment.

Image: Money Racket
By at Money Racket · Jul 10, 2026

The FDA granted a supplemental approval for Casgevy (exagamglogene autotemcel) in patients aged 2 and older with sickle cell disease or transfusion-dependent beta thalassemia. The drug was previously approved only for patients 12 and up. This is the first gene therapy cleared for young children with sickle cell disease.

Who cashes in: Vertex Pharmaceuticals (VRTX) and CRISPR Therapeutics (CRSP) co-developed and co-commercialize Casgevy. Vertex holds the larger commercial rights and books the majority of revenue. The label expansion matters because sickle cell disease is more prevalent and more severe in younger patients — catching children at 2 rather than 12 means more eligible patients and earlier intervention, which is the clinical and commercial argument for the expanded label. At a list price above $2 million per patient, even a modest increase in treated volume is meaningful revenue. bluebird bio (BLUE) has a competing sickle cell gene therapy (Lyfgenia) but remains under significant financial pressure and is not a direct beneficiary here.

At a list price above $2 million per patient, even a modest increase in treated volume is meaningful revenue for Vertex.

Who's exposed: bluebird bio (BLUE) faces continued competitive pressure from Casgevy's expanding label. Its own therapy has a narrower approved population and a more complex safety profile that has slowed uptake. The Casgevy pediatric expansion reinforces Vertex/CRISPR's first-mover advantage in the gene therapy space for hemoglobinopathies.

What to watch: Actual treatment center capacity for pediatric patients. Gene therapy requires specialized facilities, and the bottleneck on revenue is how quickly authorized treatment centers can handle younger, smaller patients — not the label itself.

Source: original report ↗

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